acarbose

Generic: acarbose

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acarbose
Generic Name acarbose
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acarbose 50 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0141
Product ID 0054-0141_2d7f6918-65c3-4db3-b775-b74e1e637cea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078470
Listing Expiration 2026-12-31
Marketing Start 2008-05-07

Pharmacologic Class

Established (EPC)
alpha-glucosidase inhibitor [epc]
Mechanism of Action
alpha glucosidase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540141
Hyphenated Format 0054-0141

Supplemental Identifiers

RxCUI
199149 199150 200132
UPC
0300540140250
UNII
T58MSI464G
NUI
N0000000166 N0000175559

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acarbose (source: ndc)
Generic Name acarbose (source: ndc)
Application Number ANDA078470 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0054-0141-25)
source: ndc

Packages (1)

0054-0141-25 100 TABLET in 1 BOTTLE (0054-0141-25)

Ingredients (1)

acarbose (50 mg/1)

Linked Drug Pages (1)

Acarbose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d7f6918-65c3-4db3-b775-b74e1e637cea", "openfda": {"nui": ["N0000000166", "N0000175559"], "upc": ["0300540140250"], "unii": ["T58MSI464G"], "rxcui": ["199149", "199150", "200132"], "spl_set_id": ["352dd336-d3f9-4ac5-a000-91d3aef7aca3"], "pharm_class_epc": ["alpha-Glucosidase Inhibitor [EPC]"], "pharm_class_moa": ["alpha Glucosidase Inhibitors [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0054-0141-25)", "package_ndc": "0054-0141-25", "marketing_start_date": "20080507"}], "brand_name": "Acarbose", "product_id": "0054-0141_2d7f6918-65c3-4db3-b775-b74e1e637cea", "dosage_form": "TABLET", "pharm_class": ["alpha Glucosidase Inhibitors [MoA]", "alpha-Glucosidase Inhibitor [EPC]"], "product_ndc": "0054-0141", "generic_name": "Acarbose", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acarbose", "active_ingredients": [{"name": "ACARBOSE", "strength": "50 mg/1"}], "application_number": "ANDA078470", "marketing_category": "ANDA", "marketing_start_date": "20080507", "listing_expiration_date": "20261231"}